Recruiting

Low-Dose Radiotherapy

Sponsor:

University of Southern California

Code:

NCT03858205

Conditions

Bone Pain

Metastatic Malignant Neoplasm in the Bone

Plasma Cell Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality-of-Life Assessment

Questionnaire Administration

Radiation Therapy

Study Details

Brief summary:

This phase II trial studies how well low-dose radiotherapy works in treating bone pain in patients with multiple myeloma that has spread to the bone. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. Low-dose radiotherapy may be more convenient for patients and their families, may not interfere as much with the timing of chemotherapy, and may have less chance for short term or long-term side effects from the radiation.

Conditions

Bone Pain

Metastatic Malignant Neoplasm in the Bone

Plasma Cell Myeloma

Study ID

NCT03858205

Start date

Mar 11, 2019

Status verified date

Jun, 2026

Completion date

Mar 11, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologic diagnosis of multiple myeloma
  • Painful bone metastasis (index lesion) that has a radiographic correlate
  • Patient may have had any number of prior chemotherapy/immunotherapy regimens (changes to systemic therapy or use of bisphosphonates for 4 weeks before and after RT are allowed, but recording of these changes must be made so it can be accounted for)
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Brief Pain Inventory (BPI) score >= 2
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients will be ineligible if the index lesion has received prior radiation therapy or prior palliative surgery. Patients may have received prior palliative or primary radiotherapy or surgery to other parts of the body, as long as the index lesion was not in the prior radiation fields and has not received prior palliative surgery
  • Patients will also be ineligible if there is pathologic fracture or impending fracture at the site of the index lesion or planned surgical fixation of the bone at the index lesion
  • Patients with clinical or radiographic evidence of spinal cord or cauda equina compression/effacement from the index lesion, and/or with index lesions located at the skull base or orbital lesions
  • Patients must not be pregnant

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (low-dose radiation therapy)

Patients receive low-dose radiation therapy at consecutive business days 1 and 2 in the absence of disease progression or unacceptable toxicity. Patients with no pain relief may receive additional radiotherapy at 4 weeks following initial radiotherapy.

Interventions

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Radiation Therapy

Receive low-dose radiation therapy

Primary outcome measure

  • Pain response [ Time Frame: Up to 6 months after completion of radiation therapy ]

Central Contacts and Locations

Central contacts

Christine Duran

323-865-0371Duran_C@med.usc.edu

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Bianca Del Vecchio

626-218-4402bdelvecchio@coh.org

Principal Investigator:

Savita V Dandapani, MD

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Donna Fernando, RN

323-409-4388Donna.fernando@med.usc.edu

Principal Investigator:

Adam Garsa, MD

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Donna Fernando, RN

323-409-4388Donna.fernando@med.usc.edu

Principal Investigator:

Adam Garsa, MD

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Chace Henning

310-423-8218chace.henning@cshs.org

Harpavan Sandha

310-423-4849harpavan.sandha@cshs.org

Principal Investigator:

Leslie Ballas, MD

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Mohammad K. Khan

404-778-3473Drkhurram2000@gmail.com

Principal Investigator:

Mohammad K. Khan

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Patrick Boyle

617-582-8918PJBoyle@dfci.harvard.edu

Carol Mayo

508-488-3800CMAYO@PARTNERS.ORG

Principal Investigator:

Andrea K. Ng

University of Minnesota - Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Kate Bak

612-301-0151kbak@umn.edu

Principal Investigator:

Stephanie Terezakis, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Richard L. Bakst

212-241-3545Richard.bakst@mtsinai.org

Principal Investigator:

Richard L. Bakst

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jhohanna Perez

267-299-9643RadOncCRU@PennMedicine.upenn.edu

Principal Investigator:

John Plastaras, MD, PhD

More Information

Sponsor

University of Southern California

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-06-05.